cleaning documentation is accurately maintained.

Maintenance Team: Ensures that any necessary maintenance is performed during the cleaning process and ensures proper reassembly of the equipment.

Production Supervisor: Oversees the cleaning process, ensuring adherence to this SOP, and confirms that the drying trays and racks are ready for use in the next production batch.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule drying trays and racks are cleaned according to this SOP. The QA Manager is responsible for ensuring compliance with GMP and verifying that all cleaning documentation is complete and accurate.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, ensure the following:

1. Turn Off the Equipment
   1. Ensure that the drying trays and racks are turned off, and the power supply (if any) is disconnected to avoid any electrical hazards during cleaning.
2. Gather Cleaning Materials
   1. Collect necessary cleaning materials, including warm water, non-abrasive cleaning agents, brushes, lint-free cloths, sponges, and Personal Protective Equipment (PPE) for safety.
   2. Ensure that all cleaning agents are compatible with the material of the drying trays and racks and non-corrosive.
3. Prepare Cleaning Log
   1. Ensure that the Cleaning Log (Annexure-1) is ready to record cleaning actions, the name of the operator, the time, and any deviations during the process.

5.2 Disassembling the Drying Trays and Racks

If necessary, disassemble the trays and racks for proper cleaning:

1. Remove Components for Cleaning
   1. Carefully disassemble the trays and racks, including removable trays, filters, and any other detachable components.
   2. Handle each part with care to avoid damage to any sensitive components.
2. Label Disassembled Parts
   1. Label each disassembled component to ensure correct reassembly after cleaning.
3. Place Components in Cleaning Stations
   1. Place all disassembled parts in the designated cleaning stations for thorough washing.

5.3 Cleaning Process

Follow these steps to clean the drying trays and racks:

1. Initial Rinse
   1. Rinse the trays and racks with warm water to remove any residues, dust, or particles from the previous batch.
   2. Ensure all areas, including internal parts, are rinsed thoroughly.
2. Apply Cleaning Agents
   1. Apply an approved, mild, non-abrasive cleaning agent to the trays and racks. Use soft brushes to scrub surfaces and remove any remaining residues.
3. Rinse with Warm Water
   1. Rinse all parts thoroughly with warm water to remove any cleaning agents and contaminants.
   2. Ensure that no cleaning agents remain on the trays or racks.
4. Disinfect (If Required)
   1. If necessary, apply an appropriate disinfectant to the trays and racks to prevent microbial contamination.
   2. Follow the manufacturer’s instructions for proper dilution and use of disinfectants.
5. Final Rinse
   1. Perform a final rinse with clean warm water to ensure that all disinfectant or cleaning agents are removed.

5.4 Drying and Reassembly

After cleaning, proceed with drying and reassembly:

1. Dry the Components
   1. Dry the cleaned trays and racks with a clean, dry, lint-free cloth. Allow parts to air dry completely if necessary.
2. Reassemble the Equipment
   1. Once dry, carefully reassemble the trays and racks, ensuring all parts are correctly reinstalled and securely fastened.

5.5 Post-Cleaning Inspection

Once cleaning and reassembly are completed, perform the following checks:

1. Inspect for Residual Contamination
   1. Visually inspect the trays and racks for any remaining cleaning agents, residues, or contamination. If contamination is detected, repeat the cleaning process.
2. Check for Proper Reassembly
   1. Ensure that all components are correctly reassembled and securely fastened.
3. Run Test Batch
   1. Run a small test batch of capsules to ensure that the trays and racks are functioning properly and there is no contamination from the previous batch.

5.6 Documentation

Ensure that the cleaning process is properly documented:

1. Complete Cleaning Log
   1. Record all cleaning actions, including date, time, operator, actions taken, and any observations or deviations in the Cleaning Log (Annexure-1).
2. Post-Cleaning Inspection
   1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Cleaning Log (Annexure-1)
2. Equipment Inspection Log (Annexure-2)
3. Maintenance Log (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Batch ID	Cleaning Date	Operator	Cleaning Action	Comments
Batch 001	02/02/2025	John Doe	Disassembled and cleaned drying trays and racks	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Drying Tray 001	02/02/2025	No defects found, equipment fully operational	Jane Smith	02/02/2026

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Drying Tray 001	02/02/2025	Cleaned and recalibrated tray rack system	John Doe	02/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version	New SOP Creation	QA Head
01/02/2025	2.0	Updated cleaning steps and added post-cleaning inspection	Improved process accuracy	QA Head